Concern Over National Shortage of HRT Products

Peter Russell

August 12, 2019

A significant national shortage of hormone replacement therapy (HRT) was described as "incredibly concerning" by GPs.

The Royal Pharmaceutical Society said it was "worrying and frustrating" for patients.

The Department of Health and Social Care (DHSC) said it was aware of the problem and was working closely with suppliers to maintain availability to patients.

Prof Helen Stokes-Lampard, chair of the Royal College of GPs (RCGP), said in a statement: "It's not entirely clear why there is currently a shortage of these HRT drugs – it seems as though there are several factors at play – or how long it'll last, but it is already having a massive impact on our patients' lives, and needs to be addressed as a matter of urgency so that patients across the UK are able to continue accessing the care and treatment they need and deserve."

Supply and Manufacturing Problems

The British Menopause Society (BMS) said some of the supply problems were down to manufacturing shortages, while others were related to supply issues.

On Friday, it listed products which it said were currently unavailable. These included:

  • Evorel patches (Janssen - estradiol), most of which could remain out of stock until the autumn. It said the manufacturer had indicated that shortages were caused by an unusual increase in demand.

  • Mylan was experiencing shortages of Elleste Solo: 2mg oestradiol; Elleste Duet 1mg oestradiol + 1mg norethisterone acetate; Elleste Duet Conti 2mg oestradiol + 1mg norethisterone; Femoston 1mg oestradiol + 10mg dydrogesterone; Zumenon 1mg oestradiol and 2mg oestradiol; Elleste Solo MX patches 40mcg transdermal oestradiol; Elleste Solo MX patches 80mcg transdermal oestradiol

  • Estraderm MX 50 (Novartis) patches (pack of 8) were available but in short supply

Earlier this year the BMS advised prescribers to search for equivalent types by looking at the oestrogen and progestogen component and matching it as closely as possible to another brand.

The DHSC said it was first made aware in late December last year of a supply problem with Elleste due to manufacturing issues caused by regulatory action at Mylan's contract manufacturing site.

It said Mylan had since replenished some stock and anticipated that stocks of other products in the range should be available from the middle of August.

Long-term stock issues affected FemSeven Sequi (Theramex - estradiol with levonorgestrel) which were not expected to be resolved until towards the end of the year, it said.

The Royal Pharmaceutical Society advised in a statement: "There are alternative HRT products available. Some are equivalent to ones in shortage, but it’s not possible to provide this in every case.

"Any woman affected by the shortage should speak to her pharmacist or doctor, who should be able to suggest short-term replacements till their usual treatment becomes available again."

Increasing Workload for GPs

Prof Stokes-Lampard said: "The menopause can be a very difficult time for women, and evidence shows that for some women, hormone-replacement therapy (HRT) can really help them deal with its symptoms and improve their quality of life – so it’s incredibly concerning for both GPs and women that there are currently significant national shortages of many HRT patches and some tablets.

"Women are having to have their regular HRT doses modified, or replaced with alternatives, to accommodate for these supply problems – and not only can this cause confusion for patients regarding their treatment, but it can increase workload in general practice at a time when GPs and our teams are facing intense resource and workforce pressures.

"There is also the worry that alternatives to regular treatments might also become unavailable further down the line, and that women don’t respond to them as well as [to] their usual prescription, potentially leading to a return of their symptoms."

A DHSC spokesperson said: "Our priority is to ensure patients continue to access safe and effective medicines. We are aware of ongoing supply issues with some HRT preparations due to manufacturing delays.

"We are working closely with all suppliers to maintain overall flow of medicines to patients. Supplies of alternative HRT products are available and any patient affected should discuss alternatives with their doctor."

Pharmacists' Reaction

A spokesperson for the Company Chemists Association said: "Like all community pharmacies, from time to time our members are affected by issues relating to the supply of medicines. The UK buys its medicines in a global market and so a range of factors have an impact on medicines supply.

"Patients and the public can be confident that community pharmacy teams are working hard and doing everything they can to ensure that medicines continue to be available when people need them."

A spokesperson for Boots said: "Just like other community pharmacies, we are seeing intermittent supply from manufacturers for some lines of hormone replacement therapy.

"Where this is affecting patients, our pharmacy teams are working with them and their GP to find the right solution for the patient."

A spokesperson for Lloyds Pharmacy said: "Our priority is to make sure that patients have access to the medication they need. In the event of a stock shortage, our pharmacists will try to find an alternative source of the prescribed product. If that is not possible then we encourage them to contact the patient's GP so that they can advise on different treatment options.

"We understand the importance of transparency and communication in these situations so we try to ensure patients are kept informed throughout." 

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